Axoneme Inc.

Home

Pre-cGMP process

Production costs associated with cGMP are very high. For instance, a mammalian cell culture based 50-100 liter cGMP production costs ca. US$500 000 (Genetic Engineering News 26 (9); 2006). Axoneme is offering a pre-cGMP environment, meaning that we design and develop a bioprocess in a way that will be compliant with cGMP guidelines, but at a lesser cost. This environment, offering you the greatest flexibility reduces by at least five folds the production costs compared to cGMP production.

Flexible pilot scale

Axoneme provides expertise and equipments to scale up your process. The cultivation capacity of Axoneme ranges from a few millilitres up to more than 100 liters per week, always in a completely controlled environment, typical of automated bioreactor. Our expert team is thus able to scale up your bioprocess, from the initial small scale culture to the final steps of purification, under the most rigorous criteria of the industry.

Optimisation and determination of optimal conditions

Axoneme always works to get you with the best overall yield for the whole process. Thus, we will determine the best type of bioprocess that answer your needs, but with the constant concern to obtain the best yields possible. These optimised yields mean the greatest money and time savings possible. Moreover, Axoneme brings you great flexibility in your project management by allowing technical exchanges with our highly qualified staff, easier planning and great reactivity of your changing needs. All bioprocess developed by Axoneme gets you with:

o Production cell strain characterization
o Optimal bioprocess type
o Bioprocess scale up
o Purification process development, scale up and optimisation
o Documentation and technology transfer